A Phase 1/2 interventional study of AIV001 and Vehicle in Papulopustular Rosacea, sponsored by AiViva BioPharma, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by AiViva BioPharma, Inc. · Phase 1/2, Interventional, and Treatment
To evaluate the safety, efficacy, and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with rosacea.
This is primarily a safety study to evaluate the safety of AIV001 when administered to subjects with rosacea. Exploratory efficacy measures will also be collected as well as pharmacokinetic profiles.
231 studies on the registry are indexed under Rosacea; 20 are open to participants now.
Browse Rosacea studies →AiViva BioPharma, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Subjects randomized to vehicle will receive vehicle administration to the target area.
Drug: Vehicle
Subjects randomized to vehicle will receive AIV001 0.033% administration to the target area.
Drug: AIV001
Subjects randomized to vehicle will receive vehicle administration to the target area.
Drug: Vehicle
Subjects randomized to vehicle will receive AIV001 0.01% administration to the target area.
Drug: AIV001
Subjects randomized to vehicle will receive vehicle administration to the target area.
Drug: Vehicle
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Drug: AIV001
Subjects randomized to vehicle will receive vehicle administration to the target area.
Drug: Vehicle
Subjects randomized to vehicle will receive AIV001 0.03% administration to the target area.
Drug: AIV001
intradermal injection
intradermal injection
Rate of Adverse Events
The occurrence of adverse events will be collected and reported using MedDRA to code. Description, start and end dates, and severity will be recorded.
Time frame: Day 1 through Day 84
Efficacy evaluated by the Investigator using the Investigator Global Assessment Scale
Evaluation of rosacea within the treatment area. 0 = clear (No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia), 1 = minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia), 2 = mild (Few papules and/or pustules; mild erythema; mild to moderate telangiectasia), 3 = mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia), 4 = moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia), 5 = moderate to severe (Many papules and/or pustules; occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia), and 6 = severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia). Scores of 0 or 1 are considered success.
Time frame: Day 1 through Day 84
Efficacy evaluated by the Investigator by performing Inflammatory Lesion Counts
The number of inflammatory lesions is a static measure of the number of papules or pustules present within the treatment area.
Time frame: Day 1 through 84
Evaluation of Erythema and Topography using Standardized Photography
Photographs using standardized equipment will be taken and uploaded onto the vendor's server. The vendor will then use proprietary software to measure the amount of redness and the topography of the lesions within the treatment area.
Time frame: Day 1 through 84
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2021; primary completion for Jul 2022, 12 months later.
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This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Multi-kinase Inhbitor AIV001
AiViva BioPharma, Inc.